Methods and recommendations for evaluating and reporting a new diagnostic test

被引：67

作者：

Hess, A. S. ^{[1
]}

Shardell, M. ^{[1
]}

Johnson, J. K. ^{[1
]}

Thom, K. A. ^{[1
]}

Strassle, P. ^{[1
]}

Netzer, G. ^{[1
]}

Harris, A. D. ^{[1
]}

机构：

[1] Univ Maryland, Sch Med, Baltimore, MD 21201 USA

来源：

EUROPEAN JOURNAL OF CLINICAL MICROBIOLOGY & INFECTIOUS DISEASES | 2012年 / 31卷 / 09期

关键词：

LATENT CLASS ANALYSIS; DISCREPANT ANALYSIS; TEST PERFORMANCE; ACCURACY; BIAS;

D O I：

10.1007/s10096-012-1602-1

中图分类号：

R51 [传染病];

学科分类号：

100401 ;

摘要：

No standardized guidelines exist for the biostatistical methods appropriate for studies evaluating diagnostic tests. Publication recommendations such as the STARD statement provide guidance for the analysis of data, but biostatistical advice is minimal and application is inconsistent. This article aims to provide a self-contained, accessible resource on the biostatistical aspects of study design and reporting for investigators. For all dichotomous diagnostic tests, estimates of sensitivity and specificity should be reported with confidence intervals. Power calculations are strongly recommended to ensure that investigators achieve desired levels of precision. In the absence of a gold standard reference test, the composite reference standard method is recommended for improving estimates of the sensitivity and specificity of the test under evaluation.

引用

页码：2111 / 2116

页数：6

共 22 条

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